- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756529
The Effect of Hand Massage on Pain, Anxiety, Fear and Nausea After Surgery in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Due to various diseases throughout their developmental period, children find themselves in an environment where painful procedures are performed that they have not experienced before, and they remain in the hospital due to their illnesses. Surgical procedures constitute a portion of children's hospitalizations. Being exposed to unknown tools and physically painful procedures, being away from the family, and being in a foreign environment are situations that cause the child and family to experience anxiety. Children's anxieties about illness and hospital cause negative consequences such as prolonged recovery time and increased need for pain and sedative medication. Children's fears and anxieties about injuries and medical procedures reduce compliance with the treatment process and cause treatment to be delayed or postponed. Excessive anxiety hinders children's effectiveness in coping with medical treatment and increases uncooperative behavior and negative emotions toward healthcare professionals. Anxiety and pain are considered two common problems experienced by children before and after surgery. Pain causes changes in the brain and makes future pain worse. It slows healing, impairs treatment, and causes medical problems. Untreated pain causes anxiety, depression, irritability, and fatigue. Pain is a common consequence of surgery worldwide, and unrelieved or poorly managed pain is a burden on the child, the healthcare system and society.
Many patients described nausea and vomiting as the most unpleasant surgery-related experience they had in the postoperative period, even more than pain. In particular, prolonged hospital stay leads to re-admission and therefore increased treatment costs. At the same time, it causes the time allocated for nursing care to be prolonged, causing negative reflections on work-time management and therefore on the quality of patient care. Therefore, early detection and prevention of postoperative nausea and vomiting is very important for the satisfaction of the child and family and the quality of care.
In the literature, many non-pharmacological applications such as letting sick children listen to music, virtual reality glasses, and games after surgery have been performed and their effects on parameters such as pain, nausea-vomiting, and anxiety have been examined. Although there are studies examining the relationship between postoperative hand massage and anxiety, pain, fear and nausea in children, they are limited. Therefore, the aim of this study is to determine the effect of hand massage on anxiety, pain, fear and nausea and vomiting in children who have ingunial hernia surgery and are hospitalized in the pediatric surgery clinic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Palandöken
-
Erzurum, Palandöken, Turkey, 25000
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Are between the ages of 7-12,
- Pediatric patients who are scheduled for ingunial hernia surgery,
- Volunteers to participate in the research,
- Those whose families agree to participate in the research
- No communication problems (vision, hearing, mental),
- For patients in the experimental group; All patients who did not have an infectious disease on the hand skin (shingles, fungus, eczema, warts, calluses), local infection (abscess, etc.), open lesion/wound, scar tissue, edema, hematoma, recent fracture or dislocation were included in the sample.
Exclusion Criteria:
- Being outside the 7-12 age range,
- Pediatric patients for whom ingunial hernia surgery is not planned,
- Those who do not volunteer to participate in the research,
- The family does not agree to participate in the research
- Having communication problems
- For patients in the experimental group, patients with infectious diseases, lesions, open wounds, hematomas, fractures-dislocations on the skin of the hands were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
group receiving hand massage
|
Hand massage was applied to the patients before surgery, on the morning of surgery and after surgery.
Other Names:
|
|
No Intervention: control group
Group without hand massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Scale
Time Frame: one day before surgery
|
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety.
If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given.
The total score obtained from each scale is between 20-80.
|
one day before surgery
|
|
State-Trait Anxiety Scale
Time Frame: the morning of surgery
|
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety.
If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given.
The total score obtained from each scale is between 20-80.
|
the morning of surgery
|
|
State-Trait Anxiety Scale
Time Frame: 1st day after surgery
|
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety.
If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given.
The total score obtained from each scale is between 20-80.
|
1st day after surgery
|
|
Wong Baker Pain Rating Scale
Time Frame: one day before surgery
|
It contains a total of 6 facial expressions.
Scoring is made between zero and five.
"I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score.
With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
|
one day before surgery
|
|
Wong Baker Pain Rating Scale
Time Frame: the morning of surgery
|
It contains a total of 6 facial expressions.
Scoring is made between zero and five.
"I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score.
With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
|
the morning of surgery
|
|
Wong Baker Pain Rating Scale
Time Frame: 1st day after surgery
|
It contains a total of 6 facial expressions.
Scoring is made between zero and five.
"I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score.
With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
|
1st day after surgery
|
|
Medical Fear Scale
Time Frame: one day before surgery
|
This scale is a three-choice Likert type scale.
For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated.
The lowest score on the scale is 27 and the highest score is 87.
Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
|
one day before surgery
|
|
Medical Fear Scale
Time Frame: the morning of surgery
|
This scale is a three-choice Likert type scale.
For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated.
The lowest score on the scale is 27 and the highest score is 87.
Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
|
the morning of surgery
|
|
Medical Fear Scale
Time Frame: 1st day after surgery
|
This scale is a three-choice Likert type scale.
For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated.
The lowest score on the scale is 27 and the highest score is 87.
Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
|
1st day after surgery
|
|
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time Frame: one day before surgery
|
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
|
one day before surgery
|
|
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time Frame: the morning of surgery
|
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
|
the morning of surgery
|
|
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time Frame: 1st day after surgery
|
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
|
1st day after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fatma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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